The safety assessments requirements of cosmetic products in the EU and
worldwide

Glossary over The safety assessments requirements of cosmetic products in the EU and
worldwide

Active ingredient

The term “active ingredient” is mostly used in drugs to name the substance
which is pharmaceutically active.

The term “active substance” is also used in biocidal products to name the
component which actually kills, or otherwise controls pests or bacteria.

It is not necessarily the largest or most hazardous component of the product.
Some products may contain more than one active ingredient or substance.
Non-active ingredients are often called inert ingredients.
(Source: GreenFacts)

Allergy

Allergies are inappropriate or exaggerated reactions of the immune system to
substances that, in the majority of people, cause no symptoms.

Symptoms of the allergic diseases may be caused by exposure of the skin to a
chemical, of the respiratory system to particles of dust or pollen (or other
substances), or of the stomach and intestines to a particular food.
(Source:
ACAAIAllergy-Immunology
Glossary
)

Bacteria are a major group of micro-organisms that live in soil, water,
plants, organic matter, or the bodies of animals or people. They are microscopic
and mostly unicellular, with a relatively simple cell structure.

According to the Biocides Directive (98/8/EC), biocidal products are those
that are intended to destroy, render harmless, prevent the action of, or
otherwise exert a controlling effect on any harmful organism by chemical or
biological means. Examples include disinfectants, preservatives, antiseptics,
pesticides, herbicides, fungicides and insecticides.

Biocidal products mentioned in the Biocides Directive are listed in the
following table:
(Source: GreenFacts, based on the
Biocides Directive (98/8/EC)
)

Any one of a group of diseases that occur when
cells in the body become abnormal and have
the potential to spread and establish growth in nearby
tissues and other parts of the body
(malignancy).
(Source: GreenFacts )

A substance that is either present in an environment where it does not belong
or is present at levels that might cause harmful effects to humans or the
environment.
(Source: GreenFacts)

Dibutyl phthalate (DBP)

DBP, also known as DNBP, is a phthalate with the same core structure as
DIDP and
DINP but with two shorter side chains
attached, each having four carbon atoms.

In the 1990s, over 75% of DBP was used as plasticiser in plastics such as
PVC, 14% in adhesives, 7% in printing inks
and 3% in other miscellaneous uses, including sealants and grouting agents used
in construction as well as consumer products. For instance, it was used as an
additive to perfumes, deodorants, hair sprays, nail polish, printer inks, and
insecticides.

"ECHA is the driving force among regulatory authorities in implementing the
EU's groundbreaking chemicals legislation for the benefit of human health and
the environment as well as for innovation and competitiveness. ECHA helps
companies to comply with the legislation, advances the safe use of chemicals,
provides information on chemicals and addresses chemicals of concern."
(Source:
https://echa.europa.eu/home
)

European Union

"The European Union (EU) is a family of democratic European countries,
committed to working together for peace and prosperity. It is not a State
intended to replace existing states, but it is more than any other international
organisation. The EU is, in fact, unique. Its Member States have set up common
institutions to which they delegate some of their sovereignty so that decisions
on specific matters of joint interest can be made democratically at European
level.This pooling of sovereignty is also called "European integration". "
(Source:
EU website
)

Exposure

Contact of the cells of an organism with
a substance, micro-organism or
radiation. In the case of humans, this may involve contact with a
substance or agent by swallowing, breathing, or through the skin or eyes.
Exposure may be short-term [acute exposure],
of intermediate duration, or long-term
[chronic
exposure].

Exposure can be divided into external and internal.

External exposure refers to the whole dose to which an
organism is exposed.

Internal exposure refers only to that fraction of the initial
chemical dose that is absorbed and distributed throughout the body via systemic
circulation.
(Source: GreenFacts)

A colorless, pungent, and irritating volatile organic compound (VOC), with
formula H2CO, used in manufacturing and chemical industries, and as a
preservative by anatomists, embalmers, and pathologists. Potential sources in
the home include pressed wood products such as particleboard or fiberboard,
smoking, glues and adhesives, etc.

Formaldehyde is a known human carcinogen.
(Source: GreenFacts)

Fungi

Any of a group of plant-like microorganisms that include molds, mildews,
mushrooms and yeast.

Fungi lack chlorophyll and use living or dead organisms as
food by breaking them down and then absorbing the substances into their cells.
Many fungi reproduce by disseminating spores which are transported by air and
await proper conditions of moisture and temperature to germinate, grow and
reproduce.
(Source: GreenFacts
)

Human health

A state of complete physical, mental, and social well-being and not merely the
absence of disease or infirmity.

The health of a whole community or population is reflected in measurements of
disease incidence and prevalence, age-specific death rates, and life expectancy.
(Source:
MAGlossary
)

Hydrogen peroxide

Hydrogen peroxide is a highly reactive chemical containing the elements
hydrogen and oxygen.

Its structural formula is:

Pure hydrogen peroxide is a colourless liquid, but it is sold on the market as
solutions in water, containing up to 33 – 37% pure hydrogen peroxide and other
additives to stop the product decomposing.

A hazardous substance can enter the body by inhaling an airborne substance or
contaminant in the form of gas, fumes mists, vapors, dusts, or aerosols. Once
inhaled, contaminants can be deposited in the lungs and/or transported into the
blood.
(Source: GreenFacts)

In chemistry a methyl-group is an alkyl functional group with the formula
-CH3 .

This hydrocarbon unit can be found in many organic compounds, like biodiesel
(methyl ester).
(Source:
GreenFacts
)

Micro-organism

Any living organism that is too small to be seen by the naked eye such as
bacteria, viruses, protozoa, single-celled algae, and many types of fungi.
(Source: GreenFacts)

Mucous membrane

The moist layer of tissue lining the digestive, respiratory, urinary and
reproductive tracts - all the body cavities with openings to the outside world
except the ears.
(Source: 24Dr.com
Medical dictionary
)

Mutagen

A substance or physical agent that causes mutations, i.e. permanently alters
the DNA of a cell.
(Source: GreenFacts)

Particle with one or more dimensions of the order of about 100 millionth of a
millimetre (100 nm) or less.

(Note: In the SCENIHRopinion
on the appropriateness of existing methodologies to assess
the potential risks associated with engineered and adventitious products of
nanotechnologies, nanoparticles are
considered to have two or more dimensions at the nanoscale)
(Source: GreenFacts )

Phthalates are a group of man-made chemicals that are structurally related to
the organic acid, phthalic acid. The most important use of phthalates is in
plastics, especially PVC, where they act as
plasticisers.
(Source: based on the
GreenFacts Digest on phthalates)

A plasticiser is a substance which when added to a material, usually a
plastic, produces a product which is flexible, resilient and easier to handle.
(Source: Plasticisers Information Centre Frequently Asked
Questions)

Individuals or groups that are affected by a decision and have an interest in
its outcome.
(Source:
TDM Encyclopedia
Glossary
)

The European Monitoring Centre for Drugs and Drug Addiction

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) was
established in 1993.

Inaugurated in Lisbon in 1995, it is one of the EU’s decentralised agencies.

The EMCDDA exists to provide the EU and its Member States with a factual
overview of European drug problems and a solid evidence base to support the
drugs debate.

Today it offers policymakers the data they need for drawing up informed drug
laws and strategies. It also helps professionals and practitioners working in
the field pinpoint best practice and new areas of research.
(Source:
www.emcdda.europa.eu
)

The Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection

The Joint Group of Experts on the Scientific Aspects of Marine Environmental
Protection (GESAMP) is an advisory body, established in 1969, that advises the
United Nations (UN) system on the scientific aspects of marine environmental
protection.

At present GESAMP is jointly sponsored by nine UN organizations with
responsibilities relating to the marine environment, and they utilize GESAMP as
a mechanism for coordination and collaboration among them. GESAMP functions are
to conduct and support marine environmental assessments, to undertake in-depth
studies, analyses, and reviews of specific topics, and to identify emerging
issues regarding the state of the marine environment. GESAMP itself today
consists of 16 experts, drawn from a wide range of relevant disciplines, who act
in an independent and individual capacity. Studies and assessments are usually
carried out by dedicated working groups, most of whose members are not sitting
members of GESAMP but part of the broader GESAMP network.

"The FDA is responsible for protecting the public health by
assuring the safety, efficacy, and security of human and veterinary drugs,
biological products, medical devices, our nation’s food supply, cosmetics, and
products that emit radiation. The FDA is also responsible for advancing the
public health by helping to speed innovations that make medicines and foods more
effective, safer, and more affordable; and helping the public get the accurate,
science-based information they need to use medicines and foods to improve their
health."
(Source:
US FDA website
)